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European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

Team-NB position paper published: guidance for submission of technical documentation

Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…
admin
March 9, 2023
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey results: Transition to the IVD Regulation

MedTech Europe have published their Survey Report Transition to the IVD Regulation - MedTech Europe Survey Results for October 2022. This report can be found on the MedTech Europe website. The results demonstrate that there are still bottlenecks occurring throughout the IVDR implementation, and indicates where additional attention is needed.    
admin
March 9, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

EMA pilot launched for expert panels on high risk medical devices

For class III implantable devices, class IIb active devices intended to administer or remove medicinal products from the body, and Class D in vitro diagnostic medical devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate. EMA is now running a pilot that enables the expert panels to…
admin
March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC notice on the Windsor Framework

DHSC have provided the following update for stakeholders: You will have seen the announcement yesterday on the Windsor Framework, which concludes an agreement between the UK and the EU on the Northern Ireland Protocol. This framework includes simplifications to customs and Sanitary and Phytosanitary (SPS) processes that will significantly reduce requirements on traders. We are working through the details of…
admin
March 9, 2023
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Latest UKCA extensions do not apply to medical devices

This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
Natalie Creaney
November 18, 2022
Regulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Regulations: ecodesign of energy-consuming products – Regulatory Affairs Newsletter #1

Guidance for manufacturers, their authorised representatives and importers. Change made: Declaration of Conformity template added. Other pages commonly used European Commission updates MedTech Europe updates HSE eBulletins UKRI updates Home Office updates Office for Life Sciences bulletin Cabinet Office weekly update (extract of original bulletin) Environmental Agency weekly update (extract of original bulletin) MDCG updates Could consider Upcoming regulatory or…
admin
September 28, 2022
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